Effectiveness of A Mindfulness-centered Stress Management AI Chatbot to Reduce Stress and Enhance Mental Health Among Men Who Have Sex With Men in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness-centered stress management AI chatbot, Psychoeducation.
- Who it may be relevant to
- Registry conditions: Stress (Psychology). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of A Mindfulness-centered Stress Management AI Chatbot to Reduce Stress and Enhance Mental Health Among Men Who Have Sex With Men in China: A Randomized Controlled Trial Study
Overview
The goal of this randomized controlled trial is to evaluate the effectiveness of a mindfulness-centered stress management AI chatbot in reducing perceived stress and enhancing mental health among Chinese men who have sex with men (MSM). The main questions it aims to answer are: 1. Does the AI chatbot show a greater reduction in perceived stress compared to standardized psychoeducational materials? 2. Does the AI chatbot improve mental health outcomes, including depressive and anxiety symptoms, subjective well-being, and emotion regulation? Researchers will compare the AI chatbot to a control group receiving psychoeducational materials to see if the chatbot works to reduce stress and improve mental health. Participants will: 1. Be randomized to use the AI chatbot (recommended at least 2 sessions per week, 10-15 minutes per session) or read psychoeducational materials (2 times per week) for 4 weeks. 2. Complete online self-report questionnaires at baseline, post-intervention (Week 4), and 4-week follow-up.
Detailed description
Chinese MSM often experience unique social stress factors related to stigma, discrimination, and the pressures of concealing their sexual identity. These ongoing challenges are closely linked to elevated levels of anxiety, depressive symptoms, and general psychological distress. While traditional face-to-face therapy can be effective, common barriers such as waiting lists, costs, and privacy concerns frequently prevent individuals from seeking care. To help bridge this gap, the trial evaluates an accessible, private, and real-time AI tool that delivers safe, low-intensity mental health preventive support directly to a user's smartphone.
The investigational tool is a web-based chatbot built on a open-source Chinese large language model and tailored using Retrieval-Augmented Generation technology. This design ensures that the chatbot's responses are empathetic, culturally sensitive, and tailored to MSM-related stress and mental health topics. During conversations, the chatbot guides users through brief, evidence-based mindfulness practices-such as grounding, cognitive defusion, self-compassion, and sleep support-designed for 10-to-20-minute sessions. The tool focuses strictly on stress management and coping skills; it is not intended to provide clinical diagnosis, formal psychotherapy, or emergency crisis intervention.
The research follows a randomized controlled trial design spanning four weeks of intervention followed by a post-study assessment four weeks later. Adult participants with mild-to-moderate stress are recruited via major social media platforms, including Xiaohongshu, Weibo, and WeChat. After completing online consent and baseline surveys, participants are randomly assigned to either the intervention group or a control group. Those in the intervention group attend a brief online orientation and gain access to the AI chatbot, which they are recommended to use at least twice a week. Participants in the control group receive non-interactive educational readings on general stress management twice weekly. Researchers measure changes in stress levels, anxiety, depression, emotion regulation, rumination, and coping strategies across three key evaluation points.
Interventions
- Behavioral Mindfulness-centered stress management AI chatbot
An investigational, web-based conversational AI chatbot providing preventive, low-intensity psychological support for Chinese MSM experiencing mild-to-moderate stress. It has the following functions: (1) Built on a Chinese open-source LLM optimized through RAG to deliver culturally adapted, empathetic responses addressing minority stress, stigma, and identity concealment. (2) Delivers interactive, 10-20 min guided mindfulness-based stress reduction exercises (grounding, self-compassion, sleep-su - Behavioral Psychoeducation
Participants receive standardized, text-based psychoeducational readings covering general stress, coping concepts, and mental health awareness. The delivery contains no interactive features, conversational elements, or guided mindfulness coaching.
Primary outcome measures
- Score of Perceived Stress [Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.]
Secondary outcome measures (10)
- Score of Difficulties in Emotion Regulation [Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.]
- Score of Stress Coping [Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.]
- Score of Rumination [Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.]
- Score of Depressive symptom [Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.]
- Score of Anxiety Symptom [Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.]
- Score of Subjective Well-Being [Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.]
- Score of Positive and Negative Emotions [Time frame: From enrollment to the end of intervention at week 1, week 4, and week 8.]
- Score of Acceptability of Intervention [Time frame: From enrollment to the end of intervention at week 4.]
- Score of Intervention Appropriateness [Time frame: From enrollment to the end of intervention at week 4.]
- Score of AI Psychological Dialogue Quality [Time frame: From enrollment to the end of intervention at week 4.]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years.
- Chinese
- Self-identify as MSM.
- Own a smartphone to ensure compatibility with the intervention platform.
- Mild to moderate perceived stress, defined as Chinese Perceived Stress Scale (PSS-14) score < 43.
Exclusion criteria
- Diagnosed with an acute severe mental disorder, such as psychosis, major depressive disorder, or anxiety disorder;
- Currently receiving psychotherapy at enrollment.
- Report moderately severe to severe depressive symptoms, defined as a PHQ-9 total score greater than 14.
- Unable to provide online informed consent or complete study procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Hong Kong · 1 center
- The University of Hong Kong — Hong Kong
Identifiers
NCT: NCT07732621 · UW 26-192